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GB 9706.1-2020 (GB9706.1-2020)

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GB 9706.1-2020: PDF in English
GB 9706.1-2020
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 30
Replacing GB 9706.1-2007, GB 9706.15-2008
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
(IEC 60601-1:2012, MOD)
ISSUED ON: APRIL 09, 2020
IMPLEMENTED ON: MAY 01, 2023
Issued by: State Administration for Market Regulation;
Standardization Administration of the PRC.
Table of Contents
Foreword ... 4
1 Scope, object and related standards ... 11
2 Normative references ... 12
3 * Terminology and definitions ... 17
4 General requirements ... 51
5 * General requirements for testing ME EQUIPMENT ... 62
6 * Classification of ME EQUIPMENT and ME SYSTEMS ... 69
7 ME EQUIPMENT identification, marking and documents ... 70
8 * Protection against electrical HAZARDS from ME EQUIPMENT ... 96
9 * Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME
SYSTEMS ... 174
10 * Protection against unwanted and excessive radiation HAZARDS ... 204
11 Protection against excessive temperatures and other HAZARDS ... 207
12 * Accuracy of controls and instruments and protection against hazardous
outputs ... 226
13 * HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT 229
14 * PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ... 238
15 Construction of ME EQUIPMENT ... 246
16 * ME SYSTEMS ... 265
17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .. 274
Annex A (Informative) General guidance and rationale ... 275
Annex B (Informative) Sequence of testing ... 435
Annex C (Informative) Guide to marking and labelling requirements for ME
EQUIPMENT and ME SYSTEMS ... 439
Annex D (Informative) Symbols on marking ... 443
Annex E (Informative) Examples of the connection of the measuring device (MD)
for measurement of the PATIENT LEAKAGE CURRENT and PATIENT
AUXILIARY CURRENT (see 8.7) ... 452
Annex F (Informative) Suitable measuring supply circuits ... 454
Annex G (Normative) Protection against HAZARDS of ignition of flammable
anaesthetic mixtures ... 457
Annex H (Informative) PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE
and documentation ... 476
Annex I (Informative) ME SYSTEMS aspects ... 487
Annex J (Informative) Survey of insulation paths (see 8.5.1) ... 493
Annex K (Informative) Simplified PATIENT LEAKAGE CURRENT diagrams
... 496
Annex L (Normative) Insulated winding wires for use without interleaved
insulation (8.8.2) ... 499
Annex M (Normative) Reduction of pollution degrees (see 8.9.1.8) ... 503
Bibliography ... 504
Foreword
All technical content of this Part is mandatory.
GB 9706 "Medical electrical equipment" is divided into the following parts:
- Part 1: General requirements for basic safety and essential performance;
- Part 1-3: General requirements for safety - 3. Collateral standard: General
requirements for radiation protection in diagnostic X-ray equipment
- Part 2-1: Particular requirements for the safety of electron accelerators in
the range 1 MeV to 50 MeV;
- Part 2-2: Particular requirements for the safety of high frequency surgical
equipment;
- Part 2-3: Particular requirements for the basic safety and essential
performance of short-wave therapy equipment;
- Part 2-4: Particular requirements for the safety of cardiac defibrillators;
- Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy
equipment;
- Part 2-6: Particular requirements for the basic safety and essential
performance of microwave therapy equipment;
- Part 2-8: Particular requirements for basic safety and essential performance
of therapeutic X-ray equipment operating in the range 10 kV to 1 MV;
- Part 2-11: Particular requirements for the basic safety and essential
performance of gamma beam therapy equipment;
- Part 2-12: Particular requirements for basic safety and essential
performance of critical care ventilators;
- Part 2-13: Particular requirements for basic safety and essential
performance of an anaesthetic workstation;
- Part 2-16: Particular requirements for the safety of haemodialysis,
haemodiafiltration and haemofiltration equipment;
- Part 2-17: Particular requirements for the basic safety and essential
performance of automatically-controlled brachytherapy after-loading
equipment;
- Part 2-18: Particular requirements for the basic safety and essential
performance of endoscopic equipment;
- Part 2-19: Particular requirements for the basic safety and essential
performance of infant incubators;
- Part 2-22: Particular requirements for basic safety and essential
performance of surgical, cosmetic, therapeutic and diagnostic laser
equipment;
- Part 2-24: Particular requirements for the safety of infusion pumps and
controllers;
- Part 2-25: Particular requirements for the basic safety and essential
performance of electrocardiographs;
- Part 2-26: Particular requirements for the basic safety and essential
performance of electroencephalograph;
- Part 2-27: Particular requirements for the basic safety and essential
performance of electrocardiographic monitoring equipment;
- Part 2-28: Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis;
- Part 2-29: Particular requirements for the basic safety and essential
performance of radiotherapy simulators;
- Part 2-36: Particular requirements for the basic safety and essential
performance of equipment for extracorporeally induced lithotripsy;
- Part 2-37: Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring equipment;
- Part 2-39: Particular requirements for the safety of peritoneal dialysis
equipment;
- Part 2-43: Particular requirements for the safety of X-ray equipment for
interventional procedures;
- Part 2-44: Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography;
- Part 2-45: Particular requirements for the safety of mammographic X-ray
equipment and mammographic stereotactic devices;
- Part 2-54: Particular requirements for the basic safety and essential
performance of X-ray equipment for radiography and radioscopy;
- Part 2-60: Particular requirements for the basic safety and essential
performance of dental equipment;
- Part 2-63: Particular requirements for the basic safety and essential
performance of dental extra-oral X-ray equipment;
- Part 2-65: Particular requirements for the basic safety and essential
performance of dental intra-oral X-ray equipment;
- Part 2-66: Particular requirements for the basic safety and essential
performance of hearing instruments and hearing instrument systems.
This Part is Part 1 of GB 9706.
This Part is drafted in accordance with the rules given in GB/T 1.1-2009.
This Part replaces GB 9706.1-2007 "Medical electrical equipment - Part 1:
General requirements for safety" and GB 9706.15-2008 "Medical electrical
equipment - Part 1: General requirements for safety - 1. Collateral standard:
Safety requirements for medical electrical systems". This Part is based on GB
9706.1-2007 and integrates all the contents of GB 9706.15-2008. Compared
with GB 9706.1-2007, in addition to editorial changes, the main technical
changes are as follows:
- Incorporate the contents of GB 9706.15 and YY/T 0708 into this Part;
- ADD requirements for essential performance (see Clause 4);
- ADD the concept of expected service life (see 4.4);
- ADD content related to risk management (see 4.2);
- ADD different requirements for operator protection and patient protection
(see Clause 8);
- Modify the test requirements for protection against electric shock (see
Clause 8; Clause 3 of the 2007 edition);
- ADD relevant requirements for mechanical safety (see Clause 9);
- ADD fire prevention requirements (see 11.3).
This Part uses the redraft law to modify and adopt IEC 60601-1:2012 "Medical
electrical equipment - Part 1: General requirements for basic safety and
essential performance".
The technical differences between this Part and IEC 60601-1:2012 and their
reasons are as follows:
 Replace IEC 60851-6:1996+AMD1:1997 with GB/T 4074.6-2008
identical to the international standard;
 Replace IEC 60447 with GB/T 4205 identical to the international
standard;
 Replace IEC 60112 with GB/T 4207 identical to the international
standard;
 Replace IEC 60529:1989+AMD1:1999 with GB/T 4208 identical to the
international standard;
 Replace IEC 60335-1:2010 with GB 4706.1-2005 identical to the
international standard;
 Replace IEC 60950-1:2001 with GB 4943.1-2011 which modifies and
adopts the international standard;
 Replace IEC 60245-1:2003+AMD1:2007 with GB/T 5013.1-2008
identical to the international standard;
 Replace IEC 60695-11-10 with GB/T 5169.16 identical to the
international standard;
 Replace IEC 60417 with GB/T 5465.2 identical to the international
standard;
 Replace IEC 60086-4 with GB 8897.4 identical to the international
standard;
 Replace IEC 60065:2001+AMD1:2005+AMD2:2010 with GB 8898-
2011 which modifies and adopts the international standard;
 Replace IEC 60127-1 with GB/T 9364.1 which modifies and adopts the
international standard;
 Replace IEC 60601-1-3 with GB 9706.12 identical to the international
standard;
 Replace IEC 60085 with GB/T 11021 identical to the international
standard;
 Replace ISO 2878 with GB/T 11210 identical to the international
standard;
 Replace ISO 5349-1 with GB/T 14790.1 identical to the international
standard;
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
1 Scope, object and related standards
1.1 * Scope
This Part of GB 9706 specifies the GENERAL REQUIREMENTS for BASIC
SAFETY and ESSENTIAL PERFORMANCE of ME EQUIPMENT and ME
SYSTEMS.
This Part applies to MEDICAL ELECTRICAL EQUIPMENT and MEDICAL
ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME
SYSTEMS.
If a clause or subclause is specifically intended to be applicable to ME
EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause
or subclause will say so. If that is not the case, the clause or subclause applies
both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT
or ME SYSTEMS within the scope of this Part are not covered by specific
requirements in this Part except in 7.2.13 and 8.4.1.
Note 1: See also 4.2.
The 9706 series does not apply to:
- in vitro diagnostic equipment that does not fall within the definition of ME
EQUIPMENT, which is covered by the IEC 61010 series [61];
- implantable parts of active implantable medical devices covered by the ISO
14708 series [69]; or
- medical gas pipeline systems covered by ISO 7396-1 [68].
Note 2: ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and
ALARM SIGNALS.
Note 3: An asterisk (*) is used as the first character of the title or the beginning of a
paragraph or table title, indicating that there are guidelines and rationale related to
immersion “o” (GB/T 3836.6-2017, IEC 60079-6:2015, MOD)
GB/T 3836.7 Explosive atmospheres - Part 7: Equipment protection by
powder filling “q” (GB/T 3836.7-2017, IEC 60079-5:2015, MOD)
GB/T 4026 Basic and safety principles for man-machine interface, marking
and identification - Identification of equipment terminals, conductor
terminations and conductors (GB/T 4026-2019, IEC 60445:2017, IDT)
GB/T 4074.6-2008 Winding wires - Test methods - Part 6: Thermal properties
(IEC 60851-6:1996, IDT)
GB/T 4205 Basic and safety principles for man-machine interface (MMI),
marking and identification - Actuating principles (GB/T 4205-2010, IEC
60447:2004, IDT)
GB/T 4207 Method for the determination of the proof and the comparative
tracking indices of solid insulating materials (GB/T 4207-2012, IEC
60112:2009, IDT)
GB/T 4208 Degrees of protection provided by enclosure (IP code) (GB/T
4208-2017, IEC 60529:2013, IDT)
GB 4706.1-2005 Household and similar electrical appliances - Safety - Part
1: General requirements [IEC 60335-1:2004 (Ed4.1), IDT]
GB 4943.1-2011 Information technology equipment - Safety - Part 1: General
requirements (IEC 60950-1:2005, MOD)
GB/T 5013.1-2008 Rubber insulated cables of rated voltages up to and
including 450/750 V - Part 1: General requirements (IEC 60245-1:2003, IDT)
GB/T 5023.1-2008 Polyvinyl chloride insulated cables of rated voltages up to
and including 450/750 V - Part 1: General requirements (IEC 60227-1:2007,
IDT)
GB/T 5169.16 Fire hazard testing for electric and electronic products - Part
16: Test flames - 50 W horizontal and vertical flame test methods (GB/T
5169.16-2017, IEC 60695-11-10:2013, IDT)
GB/T 5465.2 Graphical symbols for use on electrical equipment - Part 2:
Graphical symbols (GB/T 5465.2-2008, IEC 60417:2007, IDT)
GB/T 6346.14-2015 Fixed capacitors for use in electronic equipment - Part
14: Sectional specification - Fixed capacitors for electromagnetic
interference suppression and connection to the supply mains (IEC 60384-
14:2005, IDT)
GB 7247.1-2012 Safety of laser products - Part 1: Equipment classification
and requirements (IEC 60825-1:2007, IDT)
GB 8897.4 Primary batteries - Part 4: Safety of lithium batteries (GB 8897.4-
2008, IEC 60086-4:2007, IDT)
GB 8898-2011 Audio, video and similar electronic apparatus - Safety
requirements (IEC 60065:2005, MOD)
GB/T 9364.1 Miniature fuses - Part 1: Definitions for miniature fuses and
general requirement for miniature fuse-links (GB/T 9364.1-2015, IEC 60127-
1:2006, MOD)
GB 9706.12 Medical electrical equipment - Part 1: General requirements for
safety - 3. Collateral standard: General requirements for radiation protection
in diagnostic X-ray equipment (GB 9706.12-1997, idt IEC 60601-1-3:1994)
GB/T 11021 Electrical insulation - Thermal evaluation and designation (GB/T
11021-2014, IEC 60085:2007, IDT)
GB/T 11210 Rubber, vulcanized or thermoplastic - Antistatic and conductive
products - Determination of electrical resistance (GB/T 11210-2014, ISO
2878:2011, IDT)
GB/T 11918.1 Plugs, socket-outlets and couplers for industrial purposes -
Part 1: General requirements (GB/T 11918.1-2014, IEC 60309-1:2012, MOD)
GB/T 11918.2 Plugs, socket-outlets and couplers for industrial purposes -
Part 2: Dimensional compatibility and interchangeability requirements for pin
and contact-tube accessories (GB/T 11918.2-2014, IEC 60309-2:2012, MOD)
GB/T 14790.1 Mechanical vibration - Measurement and evaluation of human
exposure to hand-transmitted vibration - Part 1: General requirements (GB/T
14790.1-2009, ISO 5349-1:2001, IDT)
GB/T 15092.1 Switches for appliances - Part 1: General requirements (GB/T
15092.1-2010, IEC 61058-1:2008, IDT)
GB/T 16886 (all parts) Biological evaluation of medical devices [ISO 10993
(all parts)]
GB/T 16895.21 Low-voltage electrical installations - Part 4-41: Protection for
safety - Protection against electric shock (GB/T 16895.21-2011, IEC 60364-
4-41:2005, IDT)
GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage
systems - Part 1: Principles requirements and tests (IEC 60664-1:2007, IDT)
GB/T 17465.1 Appliances couplers for household and similar general
purposes - Part 1: General requirements (GB/T 17465.1-2009, IEC 60320-
1:2007, MOD)
GB 18278.1 Sterilization of health care products - Moist heat - Part 1:
Requirements for the development, validation and routine control of a
sterilization process for medical devices (GB 18278.1-2015, ISO 17665-
1:2006, IDT)
GB 18279.1-2015 Sterilization of health care products - Ethylene oxide - Part
1: Requirements for development, validation and routine control of a
sterilization process for medical devices (ISO 11135-1:2007, IDT)
GB 18280.1-2015 Sterilization of health care products - Radiation - Part 1:
Requirements for development, validation and routine control of a
sterilization process for medical devices (ISO 11137-1:2006, IDT)
GB/T 19212.2 Safety of power transformers, power supplies, reactors and
similar products - Part 2: Particular requirements and tests for separating
transformers and power supplies incorporating separating transformers for
general applications (GB/T 19212.2-2012, IEC 61558-2-1:2007, IDT)
GB/T 23821-2009 Safety of machinery - Safety distances to prevent hazard
zones being reached by upper and lower limbs (ISO 13857:2008, IDT)
GB 27701 Mechanical safety of cathode ray tubes (GB 27701-2011, IEC
61965:2003, IDT)
GB/T 28164 Secondary cells and batteries containing alkaline or other non-
acid electrolytes - Safety requirements for portable sealed secondary cells,
and for batteries made from them, for use in portable application (GB/T
28164-2011, IEC 62133:2002, IDT)
YY/T 0316-2016 Medical devices - Application of risk management to
medical devices (ISO 14971:2007, IDT)
YY/T 0466.1 Medical devices - Symbols to be used with medical device
labels, labelling and information to be supplied - Part 1: General
requirements (YY/T 0466.1-2016, ISO 15223-1:2012, IDT)
YY 0505 Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility - Requirements
and tests (YY 0505-2012, IEC 60601-1-2:2004, IDT)
YY/T 0664-2008 Medical device software - Software life cycle processes
(IEC 62304:2006, IDT)
YY 0709 Medical electrical equipment - Part 1-8: General requirements for
safety - Collateral standard: General requirements, tests and guidance for
alarm systems in medical electrical equipment and medical electrical
systems (YY 0709-2009, IEC 60601-1-8:2003, IDT)
ISO 2882 Rubber, vulcanized - Antistatic and conductive products for
hospital use - Electrical resistance limits
ISO 3864-1:2002 Graphical symbols - Safety colours and safety signs - Part
1: Design principles for safety signs in workplaces and public areas
ISO 7000:2004 Graphical symbols for use on equipment - Index and
synopsis
ISO 7010:2011 Graphical symbols - Safety colours and safety signs -
Registered safety signs
ISO 9614-1 Determination of sound power levels of noise sources using
sound intensity - Measurement at discrete points
ISO 80000-1:2009 Quantities and units - Part 1: General
IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements
for safety - Collateral standard: Usability
IEC 60730-1:2010 Automatic electrical controls - Part 1: General
requirements
IEC 60851-3:2009 Winding wires - Test methods - Part 3: Mechanical
properties
IEC 60851-5:2008 Winding wires - Test methods - Part 5: Electrical
properties
3 * Terminology and definitions
For the purposes of this document, the following terms and definitions apply.
Note 1: Where the terms “voltage” and “current” are used in this document, they mean the
r.m.s. values of an alternating, direct or composite voltage or current unless stated
otherwise.
Note 2: The term “electrical equipment” is used to mean ME EQUIPMENT (see 3.63) or
other electrical equipment. This Part also uses the term “equipment” to mean ME
EQUIPMENT or other electrical or non-electrical equipment in the context of an
ME SYSTEM (see 3.64).
......